Recruiting

Smoking Cessation with NRT

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06883097

Conditions

Tobacco

Tobacco Abstinence

Smoking Cessation

Smoking Cessation; Tobacco Dependence

Human Immunodeficiency Virus (HIV)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Learn to Quit-HIV (LTQ-H) App

QuitStart

Study Details

Brief summary:

The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (\~6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are:

Participants will complete 5 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.

Conditions

Tobacco

Tobacco Abstinence

Smoking Cessation

Smoking Cessation; Tobacco Dependence

Human Immunodeficiency Virus (HIV)

Study ID

NCT06883097

Start date

Aug 18, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Self-reported daily cigarette smoking over the past 30 days
2. Self-reported HIV status
3. Age 18 or older
4. Desire to quit smoking
5. Willing and medically eligible to use NRT
6. Currently receiving HIV care
7. Currently owning an Android or iOS smartphone

Exclusion Criteria:

1. Current acute psychotic episode or unsafe to participate in the study
2. Pregnant or intending to become pregnant in the next 6 months
3. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
4. Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
5. Not able to fluently speak and write in English
6. Hearing, comprehension, visual, speech, or motor limitations that preclude study participation

Study Design

Enrollment

314 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Learn to Quit - HIV (LTQ-H) App

a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)

active comparator: QuitStart App

an evidence-based DTx designed for the general population

Interventions

Learn to Quit-HIV (LTQ-H) App

LTQ-H consists of 319 screens divided into: (a) HIV-tailored smoking cessation ACT skills, (b) education about tobacco dependence and treatment (USCPG), and (c) NRT psychoeducation and adherence. Content is gradually presented across 28 modules (14 education and 14 skills) that can be completed in 14 days.

QuitStart

This DTx, QuitGuide was adapted from the National Cancer Institute Smokefree.gov Initiative's QuitGuide's 5 modules have the following intervention components: (a) psychoeducation about the impact of smoking on health, (b) setting up a quit date and a quit plan, (c) selecting reasons for quitting, (d) tracking triggers and smoking habits, and (e) tips for quitting.

Primary outcome measure

  • Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks [ Time Frame: Weeks 6, 12, 18, and 24 ]

Central Contacts and Locations

Central contacts

Roger Vilardaga Vierra, Ph.D.

336-716-1495Roger.Vilardaga@wfusm.edu

Clinical Studies Coordinator

(984) 377-4306caitlyn.arnold@advocatehealth.org

Locations

Wake Forest University, Implementation Science

Recruiting

Winston-Salem, North Carolina, United States, 27101

Contacts

Principal Investigator

919-439-3498Roger.Vilardagaviera@advocatehealth.org

Clinical Studies Coordinator

(984)377-4306caitlyn.arnold@advocatehealth.org

Principal Investigator:

Roger Vilardaga

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Dec 17, 2025

Last verified

Oct, 2025

Keywords

  • Tobacco
  • Smoking Cessation
  • Human immunodeficiency virus (HIV)
  • Tobacco Abstinence
  • Quit Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-12-17.